At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
The Senior Clinical Programmer I (SrCP1) develops and coordinates clinical programming activities, maintains clinical databases and other application tools supporting data capture and data processing in compliance with study-specific plans, standard operating procedures, industry standards and regulatory requirements.
The SrCP1 provides expertise in relevant clinical programming areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff.
The SrCP1 is a member of the Data Management staff.
- Develop and maintain all clinical programming documentations in support of implementation and ongoing data management activities.
- Review and provide input/support to project teams in the development of study documentation, using technical skills to meet evolving project needs
- Develop, lead and coordinate clinical programming activities for assigned studies (including monitoring of project timelines, scope of work, budgets, resourcing needs, escalating potential problems effectively and in a timely manner and alerting management of potential change orders)
- Review, input and adhere to the requirements of study-specific data management documents & plans
- Collaborate with peers and study teams to clarify specifications and use expanded technical skills to meet evolving project needs
- Design, build, test and release clinical databases, data visualization platforms and/or data analytic reporting tools to the production environment
- Program electronic edit checks and data listings required for data review and validation process
- Lead and support application of Clinical Data Interchange Standards Consortium (CDISC) conventions during database build activities and data warehousing, i.e. CDASH, TAUGs and SDTM models
- Develop and/or validate SAS programs
- Understand and promote validation principles and consistently develop code in accordance with those requirements
- Define and promote programming best practices, training materials, global libraries and standard documents
- Maintain a broad overall knowledge in the field of clinical programming and clinical data management by reading literature, self-training, continuous professional development, attending training classes and professional meetings etc.
- Research, propose and lead process improvement initiatives
- Provide feedback on the needs of the department for tools, processes, resourcing, and personnel
Requirements
Life science, healthcare, Computer Science and/or related field degree- Minimum 5 years of relevant work experience
- Minimum 5 years of experience in drug development and/or clinical research
- Thorough knowledge of ICH-GCP(R2), GDPR/HIPPA and applicable (local) regulatory requirements
- Thorough understanding of clinical data management processes
- Good understanding and hands-on experiences of CDISC standards (i.e. CDASH, TAUGs and SDTM models)
Benefits
Benefits of working at Allucent include:
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Comprehensive benefits package per location
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Competitive salaries per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Leadership and mentoring opportunities
- Participation in our enriching Buddy Program as a new or existing employee
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Internal growth opportunities and career progression
- Financially rewarding internal employee referral program
- Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
- Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees.
About Allucent
Our mission is to help bring new therapies to light. When you work at Allucent, that means applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.
If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.
Together we SHINE. find more information about our values.
Disclaimers:
- Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices. For this role you can be home-based.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
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